Community deployment of monoclonal antibody treatment for treatment of COVID

Background New COVID-19 therapies, neutralising monoclonal antibodies (nMABs) and antivirals were rolled out for outpatient settings in England from 20th December 2021, to reduce the risk of hospitalisation or death in patients at increased risk from COVID-19. There is interest in assessing who is receiving such treatments and whether there is unwarranted variation. Aims and objectives The overall aim of this study is to provide detailed information on the NHS roll-out of antivirals and nMABs across England. This will include developing an OpenSAFELY software framework to ascertain treatment eligibility status of patients and assess the coverage of these new treatments amongst these patients, in as close to real-time as the available data flows can support. This OpenSAFELY software framework will then be used to support analyses into the effectiveness and safety of these treatments. Methods Using OpenSAFELY - a data analytics platform created by our team on behalf of NHS England to address urgent questions relating COVID-19, data from general practice records, linked to; Second Generation Surveillance System data; Secondary Uses Service data; Death registration data; A Patient-level dataset on nMABs and antiviral treatments, sourced from NHS England. The base population will consist of all eligible patients registered with a general practice using TPP in England on or after 16th December 2021 (the start of the roll out of nMABS and antiviral for COVID patients in England). The primary outcome will be treatment for COVID-19 with an antiviral or nMAB. Clinical and demographic characteristic variables will be chosen based on their availability within the primary care record and linked data, considered as likely to affect variation in treatment coverage and uptake and on their anticipated role as confounders/mediators for the treatment-outcome relationship. Simple descriptive statistics (frequencies and percentages; means and quantiles) will be used to describe eligible patients and those going on to receive treatment. This will include calculating cumulative totals of patients receiving treatment for COVID-19 and generating step charts of treatment coverage, stratified by the high risk groups. Anticipated impact and dissemination As with all OpenSAFELY outputs, all software and analytical code will be openly shared for inspection and re-use by anyone. We will develop manuscripts for submission to high impact peer-reviewed journals and develop dashboards describing the clinical and demographic characteristics of recipients and we will routinely update these on https://reports.opensafely.org/ to support ongoing monitoring of the roll-out of nMABs and antivirals. Timelines for delivery We aim to have a first version of our descriptive analysis manuscript out by early March 2022, alongside weekly treatment coverage reports which will be updated regularly with extended follow-up time using near real-time data as the treatment programme progresses. Manuscripts on effectiveness and safety will follow shortly in the months thereafter.